Collecting information
Organizing data
Conduct in-service education programs on OSHA, CDC, and JC requirements to enhance staff knowledge of regulatory standards.. Lead the JC Task Force to ensure ongoing compliance and accreditation readiness.. Education: Bachelor's degree in Nursing, Healthcare Administration, or a related field (required).. Working knowledge of hospital operations, JC standards, CMS requirements, and DOH regulations (required).. In-depth understanding of healthcare regulations with a focus on patient safety and performance improvement.
Regulatory Affairs Manager - Bilingual (Mandarin & English)Regulatory Affairs Manager - Bilingual (Mandarin & English). Get notified about new Regulatory Affairs Manager jobs in San Diego, CA. Associate Regulatory Affairs Manager (San Diego). Senior Regulatory Affairs Manager (Onsite)Regulatory Affairs Associate Director or Senior Manager. Staff Regulatory Affairs Specialist - Becton DickinsonStaff Regulatory Affairs Specialist (Hybrid) - Becton DickinsonStaff Regulatory Affairs Specialist (Hybrid)
Job Title: Long-Term Care Medical Biller. Ensure proper coding of services using ICD-10, CPT, and HCPCS codes to maximize reimbursement and minimize denials.. Prepare, review, accurately process, and submit institutional claims (UB-04) for long-term care services, including skilled nursing, rehabilitation, and other related services in a timely fashion for Medicaid, Medicare, Advantage Plans ensuring timely filing, compliance with payer guidelines and contractual obligations.. Knowledge of UB-04 billing, ICD-10, CPT, HCPCS codes, payer guidelines for Medicare, Medicaid, and commercial insurance.. Proficiency in medical billing software and electronic health record (EHR) systems (e.g., PointClickCare, MatrixCare, or similar).
Senior Clinical Research Coordinator - Cell Therapy. Position Title: Senior Clinical Research Coordinator - Cell Therapy. The Clinical Research Coordinator Senior will manage clinical research studies by coordinating and overseeing a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.. The Senior Clinical Research Coordinator (Sr. CRC) plays a key-role in complex clinical trials focused on cellular therapies, including CAR-T and other investigational treatments.. Collaborate on developing and implementing centralized support for cell therapy and early-phase trials.
Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Nuvalent pipeline is currently focused on development of precision medicines for oncology targets; therefore, the physician will work closely with a multi-disciplinary team consisting of non-clinical safety, DMPK/clinical pharmacology, biostatistics, clinical operations, data management, pharmacovigilance, and regulatory affairs. Be the clinical lead for clinical trials, including performing detailed review and evaluation of molecular pathology reports for eligibility, and ongoing monitoring of clinical and laboratory data, assessing safety, and responsibility for analysis of emerging safety and clinical signals. Provide Pharmacovigilance support for the clinical trials in conjunction with our PV team.. Thorough understanding of the drug development process from IND through NDA, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations and pharmacovigilance
We're looking for a Director, Regulatory Affairs to lead the development and execution of regulatory strategies for our cutting-edge Specialty pipeline.. As a Director of Regulatory Affairs in our Global Regulatory Affairs team, you'll play a pivotal role in shaping and delivering regulatory strategies that support the development and approval of innovative specialty medicines.. Proven experience in Regulatory Affairs within the pharmaceutical industry. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Ensures adherence is being maintained with all Board of Pharmacy requirements regarding pharmacy operations, licensure, and pharmacy construction activities.. Manage negotiations and renewals with third-party payers for Medicare, Medicaid and Commercial plans.. Design, implement, and oversee the Pharmacy Quality Assurance Program to promote patient safety and regulatory compliance.. Works to support government affairs and relations activities with state organizations.. Valid Immunization License in the state practicing pharmacy, if required by state regulations.
destinationone Consulting specializes in recruitment across diverse sectors, including Healthcare, Health Tech, Government, Municipalities, Non-Profits, Legal, Public Accounting, Food and more.. The Quality Assurance Coordinator is responsible for monitoring and evaluating the quality of care provided within the healthcare practice, ensuring that standards are met and continuously improved.. Bachelor's degree in Healthcare Administration, Nursing, or a related field; certification in quality management preferred.. Experience in quality assurance or improvement in a healthcare setting.. Disclaimer: We're proactively building a databank for opportunities in Healthcare, Health Tech, Government, Non-Profits, Legal, and more.
The preferred candidate will have expertise in multiple therapeutic areas, including metabolic diseases and obesity, and across drug modalities, and have led regulatory filings for IND and CTA opening studies.. Plan and execute regulatory agency engagements, such as pre-IND/CTA and scientific advice meetings, serving as the primary contact with agencies like the FDA.. Advanced degree (Ph. D., PharmD, M.D., M.S., or equivalent) in a relevant scientific discipline such as pharmaceutical sciences, regulatory science, or life sciences.. Minimum of 12 years in the pharmaceutical or biotechnology industry, with at least 10 years in regulatory affairs roles.. Prior involvement in metabolic diseases, immunology, or rare disease drug development is highly desirable.
Coordinates, compiles, and submits US regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports. Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, and MDR Technical Documentation. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).. Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).. Job Segment: Regulatory Affairs, Medical Device, Compliance, Clinical Research, Medical Research, Legal, Healthcare
Regulatory Affairs Manager. LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location.. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed hybrid/remotely with onsite requirements 1 day per week.. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.. Experience serving as a Regulatory Affairs Manager performing:Laboratory and facility inspections in support of GLP studiesFacility audits as required by GLPsQMS audits of ISO/FDA elementsRegulatory agency inspectionsGCP trainingGCP compliance auditsInternal and external current GMP audits
Lead and manage end-to-end clinical trial activities (planning, execution, monitoring, and reporting) in alignment with GCP, regulatory requirements, and project timelines. Collaborate with cross-functional teams including R&D, regulatory affairs, QA, and data science to ensure study objectives are met. Ensure compliance with all applicable ethical and regulatory standards including IRB/IEC submissions. Bachelor’s degree or higher in Life Sciences, Biomedical Engineering, Dentistry, Public Health, or a related field. 3–5 years’ experience managing clinical trials, preferably in medical/dental devices or digital health/AI
Oversee the preparation, documentation and conduction of Quality Assurance audits of Distribution Centers, joint Ventures, X-Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals. Serve as FDA Official Correspondent for US Facilities and US Agent for foreign HS entities.. Assist with due diligence and follow-up surveillance audits as required and serve as SME for some manufacturing partners.. RAPS and ASQ or other equivalent Certifications preferred.. Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
The Associate Director, Medical Writing is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator for the preparation of drug safety-related documents.. The responsibilities also include the coordination and preparation of Meeting Content Packages and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents, including clinical study reports, narratives, investigator’s brochures for Phase I to IV clinical trials, and drug safety-related documents.. Competency in the use of Documentum (or a similar document management system) is required, while some knowledge or experience with electronic publishing tools is desired.. Competency in the use of Documentum (or a similar document management system) is desired.. Teams within the Global Groups and Medical and Regulatory Affairs department: Medical Planning and Management Physicians, Clinical Research, Data Management, Biostatistics, Drug Safety and Pharmacoepidemiology, Regulatory, Preclinical Research.
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection.. Oversees Regulatory Operations by developing or maintaining project timelines/milestones/submission tracking systems, and document archive systems.. Get notified about new Regulatory Affairs Manager jobs in Boca Raton, FL.. Associate Director, Regulatory Affairs - Plasma Services. Research Regulatory Affairs Specialist I
Seeking Senior Regulatory Affairs SME candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This as a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary.. Provide subject matter expertise in regulatory affairs supporting MCM development pathways.. Strategize innovative regulatory approaches and strategies to MCM development against emerging threats.. Master’s degree or higher in biology, microbiology, chemistry, toxicology, pharmacy, or related field.. ProSidian Consulting has made a pledge to the Hiring Our Heroes Program of the U.S. Chamber of Commerce Foundation and the “I Hire Military” Initiative of The North Carolina Military Business Center (NCMBC) for the State of North Carolina.
The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.. Lead teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for United States and EU.. Creates and implements CMC regulatory strategies for CTA submissions and marketing applications.. Provides proactive guidance to internal groups (Quality, Manufacturing, etc) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans.. BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare preferred or equivalent relevant experience.
With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.. This position may be fully remote; however, preference will be given to San Diego-based applicants.. Working with the Executive Director, Regulatory and Medical Writing, collaborate with internal teams (e.g., Clinical Development and Biostatistics) to lead, write, and manage complex clinical regulatory documents (e.g., clinical study reports, Investigator Brochures, clinical study protocols, briefing documents, marketing application summary documents [Module 2], etc. Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents.. Rare disease experience is a plus.
Strong potential for career advancement within a leading pharmaceutical company. Bachelor’s Degree in a scientific discipline (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing). Minimum of 8 years of industry-related experience, specifically in pharmaceutical regulatory affairs strategy or US advertising and promotion. Relevant Master’s or Ph. D., or advanced scientific or law degree. 8 years of pharmaceutical experience with a focus on regulatory affairs strategy or advertising and promotion
Regulatory Affairs Project Manager (Cosmetics & OTC Drug Industry). We are seeking a highly skilled Regulatory Affairs Project Manager with specialized experience in the cosmetics and OTC drug industry.. Minimum 5 years in regulatory affairs within the cosmetics and OTC drug sector; contract manufacturing background is highly desirable.. It’s the ripple effect that changes and improves everything for your family, your community, and the world.. Sr Regulatory Affairs Specialist - Cosmetics Food Safety and Regulatory Affairs Manager R&D Food Technologist & Regulatory Affairs Specialist Quality Assurance and Regulatory Affairs Manager We’re unlocking community knowledge in a new way.